Epjevy: Withdrawal of the marketing authorisation application

pacritinib

Overview

On 7 February 2019, CTI Life Sciences Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Epjevy, for treating symptoms of myelofibrosis in patients with severe thrombocytopenia.

Key facts

Name
Epjevy
Product number
EMEA/H/C/004793
International non-proprietary name (INN) or common name
  • pacritinib
Active substance
  • pacritinib citrate
Date of withdrawal
07/02/2019
Company making the application
CTI Life Sciences Limited
Withdrawal type
Initial authorisation

Related information on withdrawals

A question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the medicine at the time of the withdrawal of the application, and includes a link to the company's formal withdrawal letter (withdrawal letter Doc. type, leave the 'Author' in properties blank).

An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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